A letter to the editor in today’s The Boston Globe by Janet Wozniak suggests that since the U.S. Food and Drug Administration (FDA) approved the use of two atypical antipsychotic medications last year for pediatric bipolar disorder, it is proof the disorder exists:
The FDA approvals of Risperdal and Abilify for this purpose not only suggest that at the proper dose, these atypical antipsychotic medications are safe and effective for use as indicated, but affirm that the FDA accepts the validity of pediatric bipolar disorder and the need to treat it.
Tortured circular logic notwithstanding, the writer — the director of (surprise, surprise!) the pediatric bipolar disorder program at Mass. General — knows that the FDA is not any kind of scientific arbiter of research into diagnoses.
The FDA has for decades widely accepted that there may be childhood versions of adult disorders (and adult versions for childhood disorders, most famously attention deficit disorder). Nobody has denied that there may indeed by a childhood version of bipolar disorder, only that the criteria to meet such a disorder are not widely accepted nor official. And therefore, prescribing these medications, while FDA-allowed, doesn’t mean we automatically should. Especially since there have been zero long-term studies conducted on teens or children with these medications. Children and teens, as the writer knows, are more susceptible to anything that might negatively impact their still-developing brains. Can the writer say with 100% certainty that these drugs, when given to a teen, won’t cause some cognitive or memory issue 10 years from now? No, and neither can anyone else.
When patients suffer, and available treatments are lacking, it is the job of experts to innovate and explore new options for hope. The approval of these drugs in children has followed the conventional and widely accepted path that begins with observations in a limited number of patients followed by small but systematic observational studies that are then validated by large, controlled trials.
According to the FDA, however, the latter is not entirely true for Risperdal’s approval:
The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.
That study included just 169 teenage subjects (not the 400 alluded to in Janssen’s press release on the approval; the additional subjects come from other studies submitted as proof of its effectiveness but that the FDA did not consider). The other studies were all open-label studies, meaning everybody knew they were receiving an active medication.
So the reality is that it only takes a medium-sized trial of 169 subjects for all of 3 weeks to get additional approvals from the FDA for a drug. Hardly overwhelming evidence.
The letter was in response to Arnold S. Relman’s op-ed 2 weeks ago which was commenting upon the alleged inappropriate pharmaceutical payments made to 3 prominent psychiatrists at Mass. General (which just also happens to be Janet Wozniak’s institution… coincidence?).
The fact is, pediatric bipolar disorder is not officially recognized by the only diagnostic system in use in the U.S. today, and its inclusion in the next revision of the system is not at all clear. Just because the FDA approves a drug for it doesn’t change this fact.